Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects

PNH Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095168
• Other study ID #: CAN106-HV-101
• Status: Completed
• Phase: Phase 1
• Start date: February 22, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2022
• Source: CANbridge Life Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Subjects must be able to understand and provide informed consent.

• Males or females, between 21 and 45 years of age, inclusive;

• Body mass index must be within the range of 18.5 to 32.0 kg/m2;

• 12-lead electrocardiogram (ECG) within normal limits with no clinically significant abnormalities in the opinion of the Investigator;

• Systolic blood pressure =140 mmHg and a diastolic blood pressure of = 90 mmHg after 5 minutes with supine rest;

• non-pregnancy

• meningococcal vaccinations for at least 2 weeks before dosing

Exclusion Criteria:

• Disease or conditions interfere with participating the trial

• Active serious mental illness or psychiatric disorder

• clinically relevant abnormal test results in hepatic function

• unacceptable CBC lab test

• asymptomatic complement deficiency

• Any other clinical safety laboratory test

• HIV, HBV, HCV positive

• Alcohol and drug abuse

• etc.

Related Conditions & MeSH terms

• PNH

Intervention

Drug:
• CAN106
CAN106 is a selective inhibitor of complement activation, which binds to the complement component C5.
• Placebo
placebo

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
CARE Pharma Shanghai Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of subjects with dose-limiting toxicity (DLTs)	TEAEs will be categorized as per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.; a DLT is defined as one subject with a Grade 3 AE or higher, that are assessed as drug-related by the site investigator.	6-months after dosing
Primary	Incidence of adverse events (AEs)	An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	6-months after dosing
Primary	Incidence of severe adverse events (SAEs)	Any untoward medical occurrence that at any dose: Results in death,; Is life-threatening,; Requires inpatient hospitalization or prolongation of existing hospitalization,; Results in persistent or significant disability/incapacity, or; Is a congenital anomaly/birth defect. (ICH E6 (R2))	6-months after dosing
Secondary	PK parameters - tmax	time to reach maximum of concentration (days)	6-months after dosing
Secondary	PK parameters-Cmax	peak plasma concentration	6-months after dosing
Secondary	PK parameters - AUC0-t	Area under the plasma concentration versus time curve to the last visit (AUCt)	6-months after dosing
Secondary	PK parameters - t1/2	terminal elimination half-life	6-months after dosing
Secondary	PD endpoints-free C5	maximal change from baseline in free C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml);	6-months after dosing
Secondary	PD endpoints-CH50	maximal change from baseline total complement activity (CH50) at each of scheduled post baseline assessment time-points (%);	6-months after dosing
Secondary	PD endpoints-total C5	meausure the absolute change from baseline in total C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml);	6-months after dosing
Secondary	Immunogenicity	Anti-drug Antibody (ADA) titers	6-months after dosing